Anticipating Decline and Providing Therapy

N/AActive Not RecruitingNCT06182995

Wake Forest University Health Sciences109 enrolled

Overview

This pilot feasibility study will be a randomized control trial of usual care following Intensive Care Unit (ICU) discharge compared to the Anticipating Decline and Providing Therapy (ADAPT) screening and support intervention. The trial aims to enroll 120 older adults (age 60 or older).

Anticipating Decline and Providing Therapy (ADAPT) is a program designed to support the implementation of a routine post-ICU cognitive impairment screening and support intervention. The program includes a routine validated cognitive screen for high-risk older adults at 6 weeks and 6 months post-ICU discharge. Patients with a screening assessment that may be consistent with cognitive impairment or dementia will receive additional resources including a specialized care plan developed by the Sticht Center for Healthy Aging and Alzheimer's Prevention. The specialized care plan is adapted from a health system-based dementia care intervention and designed to support post-ICU cognitive concerns. It was adapted with input from geriatrics, intensive care, and outpatient primary care clinicians. Also conducted are semi-structured interviews with 22 older adult ICU survivors and 6 primary care physicians to elicit preferences and the intervention was further adapted based on these results.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

109

Conditions

Cognitive Impairment Dementia Post ICU Syndrome Critical Illness Cognitive Impairment, Mild

Interventions

Usual Care post-Intensive Care Unit (ICU)BEHAVIORAL

routine clinic visits

Anticipating Decline and Providing Therapy (ADAPT)BEHAVIORAL

routine validated cognitive screen for high-risk older adults at 6 weeks and 6 months post-ICU discharge

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 60 and older at time of discharge from intensive care unit * Minimum 72 hour Intensive Care Unit stay in an ICU at Atrium Health Wake Forest Baptist * Delirium during ICU stay as determined by positive Confusion Assessment Method (CAM)-ICU score, review of clinical - documentation, or discussion with clinical team * Primary care provider in the Atrium Health Wake Forest system or intention to follow with Primary Care Physician in Atrium Health system * English speaking Exclusion Criteria: * Death during initial hospitalization and/or discharge to Hospice * Life-expectancy \< 6 months from pre-existing illness (defined as diagnosis of metastatic cancer, cirrhosis, advanced heart failure, prior palliative care referral) * Acute Traumatic Brain Injury * Continued residence in skilled nursing facility or rehab that prevents ability to complete study telephone call at time of first cognitive screen attempt * Prior history of dementia in electronic health record * Language or communication barrier that prohibits intervention participation * Participant cannot identify family or caregiver contact or family/caregiver unwilling to participate * Subject or legally authorized representative (LAR) decline consent * Unstable telephone service for contact after hospital discharge * Primary residence outside of North Carolina

Locations (1)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Number of participants in Cognitive Screening Intervention Arm

Number of participants in intervention arm who complete cognitive screening at 6 weeks

Time frame: Week 6

Secondary Outcomes

Change in Percentage of participants having mild cognitive impairment (MCI), probable dementia and the combination of either MCI or probable dementia

percentage of participants adjudicated as having mild cognitive impairment (MCI), probable dementia and the combination of either MCI or probable dementia

Time frame: Week 28

Change in number of Participants between those enrolled and those who were eligible but declined

compare pre-specified baseline characteristics (i.e., age, sex, race, ICU length of stay) between those enrolled and those who were eligible but declined

Time frame: Week 52

Number of eligible participants who complete specialized care plan development visit

Time frame: up to week 28

Change in Modified Caregiver Strain Index (MCSI) Scores

the modified caregiver strain index will be assessed via telephone call to identified caregiver or care partner in both groups - a 13-question tool that measures strain related to care provision - Scoring is 2 points for each 'yes', and 1 point for each 'sometimes' response. The higher the score, the higher the level of caregiver strain - range of 13-26

Time frame: Week 28

Change in the number of hospitalizations and Emergency Department visits

healthcare utilization will be the number of hospitalizations and Emergency Department (ED) visits

Data from ClinicalTrials.gov

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